The following data is part of a premarket notification filed by Menicon U.s.a., Inc. with the FDA for Menicon Sf-p And Menicon Z Rigid Gas Permeable Contact Lens.
| Device ID | K972443 |
| 510k Number | K972443 |
| Device Name: | MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | MENICON U.S.A., INC. 333 WEST PONTIAC WAY Clovis, CA 93612 |
| Contact | Cristina M Schnider |
| Correspondent | Cristina M Schnider MENICON U.S.A., INC. 333 WEST PONTIAC WAY Clovis, CA 93612 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-30 |
| Decision Date | 1997-08-22 |
| Summary: | summary |